Obesity refers to a condition where excess fatty tissue is accumulated in the body by genetic, environmental, and psychological factors, which results in health disorders, and may cause serious health problems such as hypertension, hyperlipidemia, heart disease, diabetes, cancer, etc. all around the world. Accordingly, the World Health Organization (WHO) defined obesity as a disease in 1996 and recognizes obesity as a risk factor for major chronic diseases, and the Management of Obesity, 2010 Recommendation of the Korean Society for the Study of Obesity, states that obesity is a disease and must be treated.
The obese population is rapidly increasing all around the world, and the WHO reported that the obese population is 1.2 billion all around the world and will increase to 1.5 billion in 2015. Moreover, according to a report by the Organization for Economic Cooperation and Development (OECD), 31% of American population and 3.2% of Korean population are extremely obese with a BMI over 30 kg/m2. Accordingly, the market for obesity drugs is rapidly growing and is expected to grow about 20% per year by 2014 based on 200 billion dollars in 2008.
However, the biggest problem in obesity treatment at present is drug abuse such as the use of unproven drugs or the abuse without the need for drug therapy. In particular, the use of antipsychotic obesity drugs should be limited to several weeks as adjuvant therapy for obesity, but is not carefully managed, resulting in a serious problem. Moreover, as the serious side effects of sibutramine, which acted as an appetite suppressant and accounted for about half of the market for obesity drugs in Korea, such as increased blood pressure, increased respiration, consciousness disorder, hypothyroidism, etc. were reported, sale of sibutramine was suspended in Europe and America in 2010, and then in Korea. Since then, the supply of phendimetrazine has increased, and thus the supply of obesity drugs is maintained at a ordinary level, but the side effects occurring during administration still remain as a serious problem.
Weight control methods for the treatment of obesity include dietary therapy, exercise therapy, behavior modification therapy, etc. in addition to the drug therapy, and the diet-related industry covers a variety of fields such as delicatessen for weight control, diet health functional foods, fitness centers, obesity clinics, etc. In particular, the Korean market for diet foods is about 150 to 200 billion Korean won and is growing annually by 7 to 10%. As the serious side effects of obesity drugs have become known to the public, much interest is focused on herb medicines that are easier to access and have fewer side effects than the obesity drugs.
Among the representative health functional foods for control weight, conjugated linoleic acids (CLA) are conjugated double bond isomers of linoleic acid, and their effects such as reduced fat absorption and suppressed fat accumulation due to inhibited lipoprotein lipase, increased basal metabolic rate (BMR) due to increased mitochondrial activity, reduced fat cells due to increased apoptosis of fat cells, etc. were reported in several experiments. Moreover, it was reported in clinical trials that when a person took about 3 g of conjugated linoleic acid on a daily basis, an average of 2.5 kg of body weight was lost after 3 months, and 15 to 20% of body fat was reduced. However, it was reported that the weight loss effects did not appear to be consistent, might increase insulin resistance, and might induce fatty liver. Therefore, there is a need for attention to the administration of conjugated linoleic acid products to patients with increased insulin resistance including type II diabetic patients.
Garcinia cambogia, another health functional food for weight control, is a plant of garcinia species originated from India, and it is known that about 10 to 30% hydroxycitrate (HCA) contained in the fruit peels of garcinia cambogia, which inhibits the action of ATP-citrate lyase, and thus inhibits the fatty acid biosynthesis and reduces the intake of fats, resulting in suppressed body weight gain. As a result of applying cambogia extracts to clinical trials based on the HCA intake, the weight loss effects due to reduced body fat, increased excretion of fat metabolites, reduced energy intake, etc. were reported, but these are short-term results obtained for a period of 10 days to 12 weeks, and a 12-week clinical trial showed that the group given a dose of 1,500 mg HCA daily had no weight loss effect, compared to the placebo group. Furthermore, there are no results of a long-term research on HCA, and thus it is difficult to make a decision on the weight loss effects.
With respect to effect, there are no health functional foods taken for the treatment of obesity, which are more effective than the drugs prescribed for the treatment of obesity at present. Moreover, due to large variations in prices between products and due to false advertisement for functionalities, consumers are confused about the selection of products, and their prices are not so low in terms of their therapeutic effects. Even some foods that are known to be effective for the weight loss can get the weight loss effects only when combined with regular exercise and diet. However, the market for products with unproven efficacy is highly concentrated due to vague expectations of the efficacy of foods, and thus there is an urgent need for the development of naturally occurring foods for which efficacy can be objectively proven.
Crataegi Fructus is a dried fruit of Crataegus pinnatifida, a deciduous tree belonging to the family Rosaceae, and is a medical herb that has been widely used in Oriental medicine for a long time, which acts on the spleen, stomach, and liver to remove indigestion, promote food digestion, and remove extravasated blood. The principal ingredients of crataegi fructus include organic acids, such crataegolic acid, citric acid, succinic acid, chlorogenic acid, caffeic acid, and oleanolic acid, and flavonoid compounds such as quercetin, vitexin, epicatechin, and rutin, and these ingredients exhibit effects on digestive organs, hypotensive effects, antibacterial effects, cardiotonic effects, etc. At present, it is reported that an extract of crataegi fructus has antioxidant effects, blood lipid inhibitory effects, etc. and exhibits weight loss effects in animal experiments.
Citri Pericarpium is a dried peel of mature fruit of citrus unshiu, an evergreen small tree belonging to the family Rutaceae, and is a medical herb that has been widely used in Oriental medicine for a long time, which acts mainly on the spleen to promote digestion and remove abdominal pain due to indigestion. The principal ingredients of Citri Pericarpium contain limonene, α, β-pinene, etc. and flavonoid compounds such as hesperidin (about 8.4%), neohesperidin, tangeritin, citromitin, 5-O-desmethyl citromitin, etc. These ingredients exhibit the effects of gastrointestinal smooth muscle relaxation, increased secretion of gastric juice, anti-stomach ulcer, anti-inflammation, etc., and it is reported that an extract of Citri Pericarpium has blood lipid inhibitory effects, weight loss effects, adipogenesis inhibitory effects, etc.
Accordingly, the present inventors have found that HT048, a composition comprising Crataegi Fructus and Citri Pericarpium, is useful for blood lipid reduction and weight loss more effectively than individual drugs, and completed the present invention.